{"id":27151,"date":"2018-11-04T13:31:49","date_gmt":"2018-11-04T12:31:49","guid":{"rendered":"https:\/\/kymos.com\/news\/impuretes-elementaires-dans-leau-purifiee\/"},"modified":"2025-12-03T18:58:33","modified_gmt":"2025-12-03T17:58:33","slug":"impuretes-elementaires-dans-leau-purifiee","status":"publish","type":"post","link":"https:\/\/kymos.com\/fr\/news\/impuretes-elementaires-dans-leau-purifiee\/","title":{"rendered":"Impuret\u00e9s \u00e9l\u00e9mentaires dans l’eau purifi\u00e9e"},"content":{"rendered":"

jeConform\u00e9ment \u00e0 la strat\u00e9gie de mise en \u0153uvre de la Ph. Eur. pour la ligne directrice ICH Q3D relative aux impuret\u00e9s \u00e9l\u00e9mentaires, le test relatif aux m\u00e9taux lourds (2.4.8) a \u00e9t\u00e9 supprim\u00e9 et une nouvelle section a \u00e9t\u00e9 ajout\u00e9e : \u00ab <\/span><\/span>Si l’eau purifi\u00e9e en vrac ne r\u00e9pond pas aux exigences de conductivit\u00e9 prescrites pour l’eau pour pr\u00e9parations injectables (0169) en vrac<\/i> (1,3 \u00b5S\/cm),<\/em> Une \u00e9valuation des risques est effectu\u00e9e conform\u00e9ment au chapitre g\u00e9n\u00e9ral 5.20 Impuret\u00e9s \u00e9l\u00e9mentaires. Cette \u00e9valuation doit prendre en compte le r\u00f4le de l’eau dans le processus de fabrication, notamment lorsque l’eau est utilis\u00e9e dans le processus mais n’est plus pr\u00e9sente dans le produit final. <\/i><\/span><\/p>\n

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Cette nouvelle section stipule que si l’ eau purifi\u00e9e<\/b> pr\u00e9sente une conductivit\u00e9 inf\u00e9rieure \u00e0 1,3 \u00b5S\/cm \u00e0 25 \u00b0C, le risque est ma\u00eetris\u00e9 et la teneur en impuret\u00e9s \u00e9l\u00e9mentaires est suffisamment r\u00e9duite pour \u00e9viter une analyse des risques. Par cons\u00e9quent, lorsque les conductivit\u00e9s se situent entre 1,3 \u00b5S\/cm<\/b> (limite pour l’eau injectable) et 5,1 \u00b5S\/cm<\/b> (limite pour l’eau purifi\u00e9e) \u00e0 25 \u00b0C, une analyse des risques doit \u00eatre r\u00e9alis\u00e9e afin de mieux conna\u00eetre les impuret\u00e9s \u00e9l\u00e9mentaires pr\u00e9sentes dans l’eau et leurs sources potentielles. Dans ce cas, le d\u00e9pistage des 24 impuret\u00e9s \u00e9l\u00e9mentaires est la m\u00e9thode la plus appropri\u00e9e pour parvenir \u00e0 des conclusions pertinentes. <\/span><\/p>\n

De nos jours, la spectrom\u00e9trie de masse \u00e0 plasma \u00e0 couplage inductif (ICP-MS) est la technologie de choix pour atteindre le faible niveau de quantification requis pour certaines impuret\u00e9s et la possibilit\u00e9 d’obtenir des r\u00e9sultats pour toutes les impuret\u00e9s en utilisant une m\u00e9thode valid\u00e9e g\u00e9n\u00e9rale en une seule injection.<\/span><\/p>\n

Une m\u00e9thode g\u00e9n\u00e9rale doit \u00eatre valid\u00e9e \u00e0 l’aide d’au moins trois \u00e9chantillons repr\u00e9sentatifs d’eau purifi\u00e9e, couvrant ainsi toute la variabilit\u00e9 potentielle. Les crit\u00e8res de s\u00e9lection doivent inclure des param\u00e8tres tels que diff\u00e9rents jours, diff\u00e9rents points d’utilisation et toute autre circonstance pertinente. La limite de quantification (LQ) d\u00e9montrable dans nos laboratoires peut atteindre des concentrations \u00e9quivalentes \u00e0 30 % de l’apport quotidien recommand\u00e9 (ADR) calcul\u00e9 en tenant compte d’une administration orale et d’une dose journali\u00e8re maximale de 4 litres. <\/span><\/p>\n

Plus pr\u00e9cis\u00e9ment, la m\u00e9thode analytique doit au plus \u00eatre capable de d\u00e9montrer que les impuret\u00e9s \u00e9l\u00e9mentaires sont inf\u00e9rieures aux concentrations suivantes, satisfaisant ainsi aux exigences de la directive ICH Q3D.<\/span><\/p>\n

Limites des impuret\u00e9s \u00e9l\u00e9mentaires :<\/strong><\/span><\/h3>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

EI<\/span><\/p>\n<\/td>\n

\n

LOQ (ppb)<\/span><\/p>\n<\/td>\n

\n

EI<\/span><\/p>\n<\/td>\n

\n

LOQ (ppb)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

CD<\/span><\/p>\n<\/td>\n

\n

0.375<\/span><\/p>\n<\/td>\n

\n

Rh<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Pb<\/span><\/p>\n<\/td>\n

\n

0.375<\/span><\/p>\n<\/td>\n

\n

Ru<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Comme<\/span><\/p>\n<\/td>\n

\n

1.125<\/span><\/p>\n<\/td>\n

\n

Se<\/span><\/p>\n<\/td>\n

\n

11.250<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Hg<\/span><\/p>\n<\/td>\n

\n

2.250<\/span><\/p>\n<\/td>\n

\n

Ag<\/span><\/p>\n<\/td>\n

\n

11.250<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Co<\/span><\/p>\n<\/td>\n

\n

3.750<\/span><\/p>\n<\/td>\n

\n

Pt<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

V<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n

\n

Li<\/span><\/p>\n<\/td>\n

\n

41.250<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Ni<\/span><\/p>\n<\/td>\n

\n

15.000<\/span><\/p>\n<\/td>\n

\n

Sb<\/span><\/p>\n<\/td>\n

\n

90.000<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Tl<\/span><\/p>\n<\/td>\n

\n

0.600<\/span><\/p>\n<\/td>\n

\n

Ba<\/span><\/p>\n<\/td>\n

\n

105.000<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Au<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n

\n

Mo<\/span><\/p>\n<\/td>\n

\n

225.000<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Pd<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n

\n

Cu<\/span><\/p>\n<\/td>\n

\n

225.000<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Ir<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n

\n

Sn<\/span><\/p>\n<\/td>\n

\n

450.000<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Os<\/span><\/p>\n<\/td>\n

\n

7.500<\/span><\/p>\n<\/td>\n

\n

Cr<\/span><\/p>\n<\/td>\n

\n

825.000<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>

Pour en savoir plus sur nos services d’analyse des \u00e9l\u00e9ments, des nitrosamines et autres impuret\u00e9s , cliquez ici.<\/a><\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":6,"featured_media":27152,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[267],"tags":[],"class_list":["post-27151","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc"],"acf":[],"yoast_head":"\nImpuret\u00e9s \u00e9l\u00e9mentaires dans l'eau purifi\u00e9e | Kymos<\/title>\n<meta name=\"description\" content=\"Apprenez-en davantage sur les tests d'impuret\u00e9s \u00e9l\u00e9mentaires dans l'eau purifi\u00e9e et sur la fa\u00e7on dont la spectrom\u00e9trie de masse \u00e0 plasma \u00e0 couplage inductif (ICP-MS) peut vous aider \u00e0 atteindre le faible niveau de quantification 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Dou\"},\"description\":\"Active in the pharmaceutical marketing for over 30 years President of CataloniaBIO&HealthTech CEO and Qualified Person at Kymos Leader of Kymos team, guaranteeing a trustable, ethical and scientific correct editorial publications. Experience Joan Puig de Dou started his career at Laboratorios Menarini first as scientist later as Qualified Person and finally as Operations General Manager. 2010 he entered Kymos where he became CEO in 2015. 2022 Joan Puig de Dou was elected as president of CataloniaBio&HealthTech to represent the Catalonian biotech industry nationally and internationally. Expertise Joan Puig de Dou has extensive experience in writing scientific content adopting a didactic approach that fits any reader\u2019s level of expertise. He publishes regularely on Kymos\u2019 webpage, social media and in the specialized press. Education He graduated from Universitat de Barcelona as Pharmacist and from IESE Business School\u2019s Programa Diecci\u00f3n General (PDG) Want to know him better? Read his interview in PharmaBoardrooom in January 2019 and more about his presidency of CataloniaBio at Parc Sc\u00edentific de Barcelona.\",\"url\":\"https:\\\/\\\/kymos.com\\\/fr\\\/news\\\/author\\\/joan-puig-de-dou\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Impuret\u00e9s \u00e9l\u00e9mentaires dans l'eau purifi\u00e9e | Kymos","description":"Apprenez-en davantage sur les tests d'impuret\u00e9s \u00e9l\u00e9mentaires dans l'eau purifi\u00e9e et sur la fa\u00e7on dont la spectrom\u00e9trie de masse \u00e0 plasma \u00e0 couplage inductif (ICP-MS) peut vous aider \u00e0 atteindre le faible niveau de quantification requis.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/kymos.com\/fr\/news\/impuretes-elementaires-dans-leau-purifiee\/","og_locale":"fr_FR","og_type":"article","og_title":"Impuret\u00e9s 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Dou","image":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/secure.gravatar.com\/avatar\/263d7ff1c7891f5821a5075a1a362a1e513db5931dc882455e887fe1c1ccf924?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/263d7ff1c7891f5821a5075a1a362a1e513db5931dc882455e887fe1c1ccf924?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/263d7ff1c7891f5821a5075a1a362a1e513db5931dc882455e887fe1c1ccf924?s=96&d=mm&r=g","caption":"Joan Puig de Dou"},"description":"Active in the pharmaceutical marketing for over 30 years President of CataloniaBIO&HealthTech CEO and Qualified Person at Kymos Leader of Kymos team, guaranteeing a trustable, ethical and scientific correct editorial publications. Experience Joan Puig de Dou started his career at Laboratorios Menarini first as scientist later as Qualified Person and finally as Operations General Manager. 2010 he entered Kymos where he became CEO in 2015. 2022 Joan Puig de Dou was elected as president of CataloniaBio&HealthTech to represent the Catalonian biotech industry nationally and internationally. Expertise Joan Puig de Dou has extensive experience in writing scientific content adopting a didactic approach that fits any reader\u2019s level of expertise. He publishes regularely on Kymos\u2019 webpage, social media and in the specialized press. Education He graduated from Universitat de Barcelona as Pharmacist and from IESE Business School\u2019s Programa Diecci\u00f3n General (PDG) Want to know him better? Read his interview in PharmaBoardrooom in January 2019 and more about his presidency of CataloniaBio at Parc Sc\u00edentific de Barcelona.","url":"https:\/\/kymos.com\/fr\/news\/author\/joan-puig-de-dou\/"}]}},"_links":{"self":[{"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/posts\/27151","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/comments?post=27151"}],"version-history":[{"count":0,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/posts\/27151\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/media\/27152"}],"wp:attachment":[{"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/media?parent=27151"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/categories?post=27151"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kymos.com\/fr\/wp-json\/wp\/v2\/tags?post=27151"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}